Activities of Soledad CABEZÓN RUIZ related to 2017/2254(INI)
Plenary speeches (1)
A European One Health Action Plan against Antimicrobial Resistance (debate) ES
Shadow opinions (1)
OPINION on a European One Health Action Plan against Antimicrobial Resistance (AMR)
Amendments (109)
Amendment 4 #
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
– having regard to the general interest paper Volume 38, Issue 1 from January 2018: "The Role of the European Food Safety Authority (EFSA) in the Fight against Antimicrobial Resistance (AMR)";
Amendment 5 #
Motion for a resolution
Citation 11 b (new)
Citation 11 b (new)
Amendment 6 #
Motion for a resolution
Citation 13 a (new)
Citation 13 a (new)
– having regard to the proposal of a regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014)558 final)
Amendment 7 #
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
– having regard to the January 2017, EFSA and EMA Joint Scientific Opinion on the measures to reduce the use of antimicrobials and the need to use antimicrobials in food producing animals ('RONAFA' opinion);
Amendment 8 #
Draft opinion
Recital A
Recital A
A. whereas antimicrobial resistance (AMR)-related challenges will increase in the years ahead and effective action is reliant on continued, cross-sectoral investments in research & innovation (R&I), so that new antibiotics, better tools, products, devices and approaches can be developed following a One Health approach;
Amendment 9 #
Motion for a resolution
Citation 14 b (new)
Citation 14 b (new)
– having regard to the ECDC- EFSA-EMA publication which investigates the association between consumption of antimicrobials and occurrence of AMR in food-producing animals and in humans; first Joint report 2015 (JIACRA I) and second 2017 (JIACRA II);
Amendment 10 #
Motion for a resolution
Citation 16 a (new)
Citation 16 a (new)
– having regard to the report of the Committee on the Environment, Public Health and Food Safety on EU options for improving access to medicines (2016/2057(INI)),
Amendment 10 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas the “Council conclusions on the next steps under a One Health approach to combat antimicrobial resistance”1a ask the Commission and the Member States to align strategic research agendas of existing EU R&D initiatives on new antibiotics, alternatives and diagnostics within a One Health Network on AMR; _________________ 1a http://www.consilium.europa.eu/en/press/ press-releases/2016/06/17/epsco- conclusions-antimicrobial-resistance/.
Amendment 12 #
Motion for a resolution
Citation 16 a (new)
Citation 16 a (new)
– having regard to ECDC Report 2016 on Antimicrobial resistance surveillance in Europe;
Amendment 14 #
Motion for a resolution
Citation 16 b (new)
Citation 16 b (new)
– having regard to the EFSA and ECDC Scientific report from February 2018, entitled “The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2016”1a _________________ 1a http://www.efsa.europa.eu/en/press/news/ 180227
Amendment 18 #
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas the Joint Programming Initiative on AMR has committed 52.95 million euro so far and further 14.4 million euro in its current call this year; whereas the IMI has seven projects on AMR, under the umbrella of the ND4BB programme, with a total budget of more than 600 million euro among European Commission funding contribution and pharma companies in kind contribution;
Amendment 21 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas 50% of antibiotics prescriptions in humans are ineffective and 25% of consumption in humans is not well administrated; whereas 30% of hospitalised patients use antibiotics and multidrug resistant bacteria poses a particular threat in hospitals, nursing homes and among patients whose care requires devices such as ventilators and blood catheters;
Amendment 21 #
Draft opinion
Recital C
Recital C
C. whereas the different funding instruments under H2020 willneed to continue delivering research results on AMR, in particular: the Innovative Medicines Initiative (IMI), with a focus on all aspects of antibiotic development including research into AMR mechanisms, drug discovery, drug development, and economics and stewardship; the European and Developing Countries Clinical Trials Partnership (EDCTP), with a focus on the development of new and improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria; the Joint Programming Initiative on AMR (JPIAMR), with a focus on consolidation of otherwise fragmented national research activities; the European Research Council (ERC), with its ‘investigator-driven’ or ‘bottom-up’ research projects; the InnovFin Infectious Diseases Financial Facility (IDFF), for close-to-market projects; and the SME Instrument and Fast Track to Innovation (FTI) which support SMEs in developing novel solutions and tools to prevent, diagnose and treat infectious diseases and improve infection control;
Amendment 23 #
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. whereas the 50% of antibiotics prescriptions in humans are inadequate and the 25% of consumption in humans are not well administrated; whereas the 30% of hospitalised people use antibiotics and the most critical group of multidrug resistant bacteria poses a particular threat in hospitals, nursing homes and among patients whose care requires devices such as ventilators and blood catheters;
Amendment 26 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Amendment 26 #
Draft opinion
Recital C b (new)
Recital C b (new)
Cb. whereas bacteria are constantly evolving, the R&D and regulatory environments are complex, targeted infections are sometimes rare and the expected returns remain limited;
Amendment 28 #
Draft opinion
Paragraph 1
Paragraph 1
1. Emphasises the need to increase funding for R&I in epidemiology and immunology for AMR pathogens and healthcare-associated infections (HAI), in new antimicrobial drug resistance mechanisms, in developing new therapeutics diagnostics and preventing measures, including vaccines, and in drug delivery technologies and approaches, such as exploiting host immunity to kill resistant microbes; points out that the study of mechanisms of antibiotic resistance and the development of medical devices for the etiology of diseases are key areas for adequate use, and appropriate prescribing of antibiotic; calls therefore not only on new drugs but on new medical devices as well;
Amendment 31 #
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas prudent antibiotic use and infection prevention and control in all healthcare sectors are cornerstones for effectively preventing the development and transmission of antibiotic-resistant bacteria;
Amendment 32 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises that AMR has become one of the most important public health problems; nevertheless, insists that, although new antibiotics are needed, the origin of the problem lies above all in the their wrong usage, making it a priority to work in this area.
Amendment 33 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Underlines the need of efficiency and coordination of research actions; welcomes therefore initiatives as the ERA- NET for establishing synergies between the Joint Programming Initiative on Antimicrobial Resistance Research and Horizon 2020;
Amendment 34 #
Motion for a resolution
Recital B
Recital B
B. whereas the misuse of antibiotics is eroding their efficacy and leading to the spread of highly resistant bacteria that are especially resistant to last-line antibiotics; whereas according to data provided by the OECD, an estimated 700 000 deaths worldwide may be caused by AMR every year; whereas 25000 of these deaths will occur in the European Union and the rest outside the EU, therefore, cooperation in development policy and coordination and monitoring of AMR at international level is crucial;
Amendment 38 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas AMR can cause up to 10 million deaths per year in 2050 if no action is taken; whereas 9 million of these estimated deaths would occur outside the EU, in developing countries, especially in Asia and Africa; whereas infections and resistance to AMR are contagious and spread easily, there is an urgent need for global action;
Amendment 38 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights the fact that AMR rates vary widely among the Member States, for which reason it is crucial to coordinate national plans with specific targets and it is in this area of coordination and monitoring of national strategies that the Commission plays a key role;
Amendment 39 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas vaccinations and rapid diagnostic tools (RDT) have the potential to limit antibiotic abuse; whereas RDT allow healthcare professionals to quickly diagnose a patient with a bacterial or viral infection and, consequently, to reduce the misuse of antibiotics and the risk of resistance developing1a; _________________ 1aWHO Global guidelines on the prevention of surgical site infection (2016), available at: http://www.who.int/gpsc/ssi-guidelines/en/
Amendment 41 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Amendment 43 #
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Recalls that health is a factor which affects productivity and competitiveness, as well as being one of the assets which is most valued by the public; stresses, therefore, that the establishment of national and European objectives to combat AMR should form part of the political and economic agenda of the EU.
Amendment 45 #
Motion for a resolution
Recital C
Recital C
C. whereas healthcare-associated infections (HAI) are often dueoccur due to lacking prevention measures which lead to antibiotic-resistant bacteria; whereas the European Centre for Disease Prevention and Control (ECDC) estimates that approximately 4 million patients acquire a HAI each year in the EU and that approximately 37 000 deaths result directly from these infections;
Amendment 45 #
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
Amendment 46 #
Draft opinion
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Stresses that a third of prescriptions are issued in primary care, for which reason the prescription guidelines ought primarily to take account of this sector.
Amendment 49 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas active screening programs with RDT have been proven to significantly contribute to the control of HAI and the reduction of the spread within hospitals and between patients1a _________________ 1aCelsus Academie voor Betaalbare zorg. Cost-effectiveness of policies to limit antimicrobial resistance in dutch healthcare organisations. Research report. January 2016. Available at: https://goo.gl/wAeN3L
Amendment 52 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the use of medical devices can prevent Surgical Site Infections and therefore prevent and control the development of AMR1a; _________________ 1aWHO Global guidelines on the prevention of surgical site infection (2016), available at: http://www.who.int/gpsc/ssi-guidelines/en/
Amendment 54 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights the fact that more than 20 new classes of antibiotics were developed until the 1960s and that only a few new types of antibiotics have reached the market since then;
Amendment 55 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
Amendment 56 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas drug-resistant TB is the leading cause of death from AMR;
Amendment 56 #
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Remembers that both institutions, the European Parliament and the Council have asked to review current incentives (i.e. orphan medicines regulation), due to the misused of them and the high final price; calls therefore on the Commission to analyse current R&D incentives models in order to design specific new ones for both, orphan medicines and antibiotics;
Amendment 57 #
Draft opinion
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Recalls on the need of transparency of real costs when there are public funds and on the delinkage of R&D costs from products prices and sales volumes; in this regard, highlights that guaranteeing affordability and access to quality antibiotics must be the final aim of R&D and incentives;
Amendment 58 #
Draft opinion
Paragraph 2 e (new)
Paragraph 2 e (new)
2e. Underlines the importance of working on a definition of R&D costs, where disbursements disconnected from the production chain and direct and indirect subsidies are subtracted;
Amendment 59 #
Draft opinion
Paragraph 3
Paragraph 3
3. Expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR; believes in the need of different models of collaboration through the impulse from the public sector and the involvement of industry; recognises that the capacities of industry play a key role in R&D of AMR; notwithstanding the above, stresses that further public priorisation and coordination are required for R&D in this urgent topic; therefore calls on the Commission to launch a Public Network for the coordination of all public funded R&D projects in AMR, similar to the European Antimicrobial Resistance Surveillance Network (EARS-Net) for surveillance;
Amendment 60 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 66 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas ECDC/EFSA/EMA are currently working on a joint mandate to provide outcome indicators for consumption of antimicrobials and AMR in food-producing animals and in humans;
Amendment 66 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Welcomes, regarding alternatives business models to promote R&D, initiatives as the Global Antibiotic Research and Development Partnership - GARDP initiative-, that explores alternative business models since the market has failed to sufficiently support the development of new antibiotics; remembers that the new business models need to be sustainable, needs-driven, evidence-based and guided by principles of affordability, effectiveness, efficiency and equity, in the benefit of patients;
Amendment 69 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Welcomes the conclusions of the “WHO, WIPO, WTO Joint Technical Symposium on Antimicrobial Resistance: how to foster innovation, access and appropriate use of antibiotics"4a where new R&D models were discussed to incentivize R&D while delinking the profitability of an antibiotic from volumes sold to correct the antibiotics market; _________________ 4a http://www.wipo.int/publications/en/detail s.jsp?id=4197.
Amendment 71 #
Motion for a resolution
Recital E b (new)
Recital E b (new)
Amendment 73 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Highlights the need of an EU data collection system on the right use of all antibiotics. asks, therefore, for the development of protocols for prescription and use of antibiotics at a EU level recognising the responsibility of veterinarians and primary care doctors among others; asks also for the compulsory collection, at a national level, of all prescriptions of antibiotics, and its registration in a database of the using and prescription of antibiotics controlled and coordinated by experts in infections to spread the knowledge on the best use of them;
Amendment 76 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
Amendment 80 #
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the systemic nature of AMR; supports the Commission’s renewed commitment to promoting EU actions and leadership in fighting AMR, including internationally; highlights the need for enhanced collaboration, including in R&I, and the role of science diplomacy, in fostering synergies and optimising resource allocation.; calls on the Commission to create partnerships as PRIMA or EDCTP for international R&D projects on Health, comprising different geographical regions and the most sensible health topics as AMR, vaccines, cancer or access to medicines;
Amendment 81 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
Amendment 85 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Believes that in order to take sufficient steps to tackle AMR, the One Health principle must play a central role, reflecting the fact that the health of people and animals and the environment are interconnected and that diseases are transmitted from people to animals and vice versa; stresses, therefore, that diseases have to be tackled in both people and animals, while also taking into special consideration the environment, which can be another source of resistant microorganisms;
Amendment 87 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Welcomes the new WHO recommendations aim to help preserving the effectiveness of antibiotics that are important for human medicine by reducing their unnecessary use in animals3a; highlights that in some countries, approximately 50-70% of total consumption of medically important antibiotics is in the animal sector, largely for growth promotion in healthy animals; asks, in the framework of the One Health approach, to include this topic in the Trade Policy of the EU and in negotiations with international organisations as WTO and associated or third countries, shaping a global policy in order to ban the use of antibiotics for fattering healthy animals; _________________ 3a http://www.who.int/foodsafety/areas_work /antimicrobial- resistance/cia_guidelines/en/.
Amendment 91 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Remembers that classic generation of antibiotics, based on a series of antibiotic modification techniques obtained from nature, is exhausted and that R&D investments to create a new generation should break the classical antibiotic paradigm; welcomes new techniques that have already being developed as for example, monoclonal antibodies that reduce the virulence of the bacteria, not killing it, but rendering it useless;
Amendment 93 #
Draft opinion
Paragraph 5 d (new)
Paragraph 5 d (new)
5d. Underlines the importance of European initiatives as the ECDC programmes for infectious diseases as AIDS, TB or Malaria, Points out that these initiatives are examples of good practices of the responsiveness and good functioning of the EU in view of the need for new antibiotics, and that the ECDC should have a key role in the priorisation of R&D needs, in the coordination of actions and involvement of all actors, in enhancing cross-sectorial work and in capacity building through R&D networks;
Amendment 94 #
Draft opinion
Paragraph 5 e (new)
Paragraph 5 e (new)
5e. Brings up the report “Tackling drug-resistant infections globally: final report and recommendations"5a that estimates the cost of taking global action on AMR is up to 40 billion USD over a 10-year period what means what is tiny in comparison to the cost of inaction and it is also a very small fraction of what the G20 countries spend on healthcare today: about 0.05 percent; calls on the Commission to analyse these figures and the possibility to impose a tax on the industry for public health in the framework of its social responsibility; _________________ 5ahttps://amr- review.org/sites/default/files/160518_Fina l%20paper_with%20cover.pdf.
Amendment 95 #
Draft opinion
Paragraph 5 f (new)
Paragraph 5 f (new)
5f. Welcomes the Davos Declaration on Combating Antimicrobial Resistance launched at the World Economic Forum in Davos on January 2016, where pharmaceutical, biotechnology and diagnostics industries “recognise the success of programmes to improve global access to drugs in HIV, TB, and malaria and call for a similar collaborative effort to address issues of access to antibiotics"6a; _________________ 6ahttps://amr- review.org/sites/default/files/Industry_Dec laration_on_Combating_Antimicrobial_R esistance_UPDATED%20SIGNATORIES _MAY_2016.pdf.
Amendment 96 #
Draft opinion
Paragraph 5 g (new)
Paragraph 5 g (new)
5g. Alerts that the FAO estimates that the use of antibiotics and pesticides in agriculture will dramatically increase; calls on the Commission and member States to study new methods to eliminate the residues of pesticides and antibiotics on food; asks, as well, for the ban of the use of last-line antibiotics in the veterinary field;
Amendment 103 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that the appropriate and prudent use of antimicrobials is essential to limiting the emergence of AMR in human healthcare, animal husbandry and aquaculture; stresses that there are considerable differences in the way Member States handle and address AMR, so the coordination of national plans with specific marked objectives becomes crucial; highlights that the European Commission plays a key role in coordinating and monitoring national strategies; calls on the Commission to consider mandatory routine collection and submission of monitoring data at EU level and to establish indictors to measure progress in the fight against AMR;
Amendment 116 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Remembers that health is a factor of productivity and competitiveness, as well as one of the issues of most concern for citizens; calls for national and European binding AMR objectives being part of the EU's political and economic agenda within the European Semester;
Amendment 133 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that establishing an effective surveillance system is essential to develop and inform any strategy aimed at rationalizing antimicrobial prescriptions and addressing AMR; recalls, however, that only a few countries have evaluated the extend of the overuse of antimicrobials; Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens;
Amendment 135 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens; calls on the Commission to draft, in consultation with EMA, EFSA, ECDC and other key stakeholders, an EU priority pathogen list (PPL) for both humans and animals, thereby clearly setting future R&D priorities;
Amendment 137 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens; calls on the Commission to encourage and support Member States to put in place and monitor national targets for the surveillance and reduction of AMR/HAIs;
Amendment 143 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
Amendment 156 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Urges the Commission to expand the role and funding of the ECDC, EFSA and EMA in the fight against AMR; believes that close collaboration between these EU agencies is paramount;
Amendment 169 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that infection prevention, biosecurity measures, active screening programs, and control practices are critical in the control of all infectious microorganisms as they reduce the need for antimicrobials and consequently opportunities for microorganisms to develop and spread resistance;
Amendment 170 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights the need for an EU data collection system on the correct use of all antibiotics; asks for the development of protocols for prescription and use of antibiotics at an EU level, recognising the responsibility of veterinarians and primary care doctors among others; furthermore, asks for the compulsory collection, at a national level, of all antibiotic prescriptions, and their registration in a database controlled and coordinated by experts in infections to spread the knowledge on the best use of them;
Amendment 172 #
6a. Stresses that compliance to infection control guidelines, integrating targets for infection rate reductions and supporting best practice all help address patient safety in the hospital environment;
Amendment 176 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Encourages Member States to prevent the spread of infection by resistant bacteria by implementing active screening programs with rapid diagnostic technologies in order to quickly identify patients infected with multi-drug resistant bacteria and to put in place appropriate infection control measures (e.g. patient isolation, cohorting and reinforced hygiene measures);
Amendment 193 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Urges the Commission and Member States to create harmonised quality standards in EU-wide curriculafollowing the One Health approach in EU-wide curricula, to foster interdisciplinary education and proper stewardship for health professionals in relation to prescribing, dosage, use, and disposal of antimicrobials and AMR contaminated materials;
Amendment 199 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Emphasises that one third of prescriptions are made in primary care, so this sector should be considered as a priority in the use protocols; stresses the need for specialists in infectious diseases for the elaboration of these protocols, their control and follow-up; calls on the European Commission to draft guidelines for their use in human health; calls on the Member States to review all existing protocols, especially for prophylactic use during surgery; welcomes current projects at national level such as the Pirasoa Project, as an example of good practice in rational use in primary care and hospitals; encourages mechanisms to share best practice and protocols;
Amendment 214 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Is aware that the cost of rapid diagnostic tools (RDT) may exceed the price of antibiotics; stresses that rapid diagnostic tests are only available across the whole country of 40% of OECD countries; calls on the Commission to propose incentives for the industry to develop effective and efficient testing methods and calls on health insurance carriers to cover the extra cost arising from the use of RDT, given the long-term benefits of preventing the unnecessary use of antimicrobials;
Amendment 242 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Warns that the FAO estimates that the use of antibiotics and pesticides in agriculture will dramatically increase; calls on the European Commission and Member States to study new methods to eliminate the residues of pesticides and antibiotics in food;
Amendment 243 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Recommends that the newly- created “One Health Network”, as well as the EU Joint Action on AMR and Healthcare-Associated Infections (EU- JAMRAI) should also involve other key relevant stakeholders apart from member states;
Amendment 247 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11 b. Recalls that, according to current legislation, antimicrobials are prohibited from being used as growth / performance enhancers in animals; highlights, however, that there is evidence of the abuse for the purposes of prophylaxis; calls on the European Commission to ban the use of antibiotics and medicated feed for prophylaxis purpose except for clearly justified cases prescribed and controlled by a veterinarian; calls for its control and the establishment of sanctions; furthermore, calls for a ban of the use of last-line antibiotics, such as Colistin and Carbapenems, in the veterinary field;
Amendment 250 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11 c. Stresses that the sanitation and hygiene of farms is fundamental; asks the Commission to develop guidelines on the use of antibiotics in animals and the hygiene conditions of farms; calls on the Member States to draw up specific plans and to strengthen control over sanitary conditions;
Amendment 261 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Stresses that affordability and broader access are key priorities and that access should be ensured for necessary new diagnostics and medicines; highlights that models for innovation, procurement, delivery and financing of treatments established for HIV/AIDS, malaria and TB could serve as a blueprint for improving access to antibiotics; calls on the European Commission to present a European plan for the eradication of the Hepatitis C, and a European Strategy for HIV/AIDS, malaria and TB;
Amendment 263 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the European Commission to explore how best to leverage the potential of the European Reference Networks for rare diseases and to assess their possible role in AMR research;
Amendment 279 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Stresses that release of pharmaceuticals into the environment is an important factor in the emergence of AMR both on a European and an international level;
Amendment 283 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Calls on the Commission to appropriately address the release of pharmaceuticals into the environment and the emergence of AMR in its strategic approach to pharmaceuticals in the environment;
Amendment 297 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Calls on the Commission to ensure that aspects of environmental protection related to antibiotic products fall within the scope of the EU Good Manufacturing Practices (GMP) to address the release of antibiotics into the environment;
Amendment 305 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14 b. Calls on the Commission and Member States to revise their Codes of Good Agricultural Practice and revise relevant best available techniques under the Industrial Emissions Directive (IED) to include provisions for the handling of manure containing antibiotics/AMR microorganisms;
Amendment 311 #
Motion for a resolution
Paragraph 14 c (new)
Paragraph 14 c (new)
14 c. Calls on the Commission to review and revise Best Available Techniques Reference (BREF) documents under the Industrial Emissions Directive (IED) relevant to emissions from the manufacturing plants of antibiotics;
Amendment 312 #
Motion for a resolution
Paragraph 14 d (new)
Paragraph 14 d (new)
14 d. Calls on the Commission to include pharmaceuticals in the watch lists for monitoring surface and groundwater under the Water Framework Directive (WFD) along with AMR in relevant microorganisms;
Amendment 317 #
Motion for a resolution
Paragraph 14 e (new)
Paragraph 14 e (new)
14 e. Calls on the Commission and Member States to ensure that environmental issues are introduced into the pharmacovigilance system for human pharmaceuticals and strengthened for veterinary pharmaceuticals particularly in relation to AMR;
Amendment 318 #
Motion for a resolution
Paragraph 14 f (new)
Paragraph 14 f (new)
14 f. Calls on the Commission and Member States to set quality standards (threshold values) or risk assessment requirements to ensure that the concentrations of relevant antibiotics and AMR microorganisms in manure, sewage sludge and irrigation water are safe before they can be spread on agricultural fields;
Amendment 319 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Points out that with an investment of EUR 1.3 billion in AMR research, Europe is a leader in this domain, and that EU achievements include the launch of the New Drugs for Bad Bugs (ND4BB) programme5 and the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR)6 ; notes with concern that no truly new antimicrobial classes have been introduced in recent years; _________________ 5 6underlines the need for efficiency and coordination of research actions; welcomes therefore initiatives such as the ERA-NET for establishing synergies between the Joint JPIAMR and Horizon 2020/FP9; highlights that more than 20 new classes of antibiotics were developed until the 1960s and notes with concern that no truly new antimicrobial classes have been introduced in recent years; _________________ 5 http://www.imi.europa.eu/content/nd4bb http://www.imi.europa.eu/content/nd4bb 6 http://www.jpiamr.eu http://www.jpiamr.eu
Amendment 321 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Welcomes that EFSA and EMA recently reviewed and discussed a number of alternatives to the use of antimicrobials in food-producing animals, some of which have been shown to yield promising results in the improvement of animal health parameters during experimental studies; recommends therefore to give new impetus to scientific research on alternatives and design an EU legislative framework that would stimulate their development and clarify the pathway for their approval;
Amendment 322 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Remembers that the traditional generation of antibiotics, based on a series of modification techniques on antibiotics obtained from nature, is exhausted and that R&D investments to create a new generation should break the traditional antibiotic paradigm; welcomes new techniques that have already been developed such as monoclonal antibodies that reduce the virulence of the bacteria, not killing it, but rendering it useless;
Amendment 337 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Encourages the European Medicines Agency (EMA) in collaboration with EFSA and ECDC to review all available information on the benefits and risks of older antimicrobial agents and to consider whether any changes to their approved uses are required;
Amendment 340 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to increase funding for early research in epidemiology and immunology of AMR pathogens, in particular the pathways of transmission between animals and humans, in health-associated infections (HAI), in new antimicrobial drug resistance mechanisms, in developing new therapeutic diagnostics and preventing measures, including vaccines, and in drug delivery technologies and approaches, such as exploiting host immunity to kill resistant microbes; points out that the study of mechanisms of antibiotic resistance and the development of medical devices for the aetiology of diseases are key areas for adequate use, and appropriate prescribing of antibiotic;
Amendment 347 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Welcomes recent cross-border research projects into antimicrobial stewardship and the prevention of infection, such as the EU-funded i-4-1- Health Interreg project; calls on the Commission to increase research funding for measures to prevent healthcare- associated infections (HAI);
Amendment 350 #
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18 b. Calls on the Commission to further support its R&D effort on AMR, including global health infections defined in the Sustainable Development Goals, especially drug resistant TB as well as Malaria, HIV and NTDs, as part of the next EU Research Framework Programme, including by dedicating a specific mission in the Programme to the global fight against AMR;
Amendment 353 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission and the Member States to promote early and continuous dialogue with all stakeholders to elaboratxplore incentives for research and development (R&D) in the field of AMR; acknowledges that there is no ‘one-size- fits-all’ approach;
Amendment 354 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Believes in the need for different models of collaboration led by the public sector and with the involvement of industry; recognises that the capacities of industry play a key role in R&D of AMR; notwithstanding the above, stresses that further public priorisation and coordination are required for R&D in this urgent topic; therefore calls on the European Commission to launch a Public Platform for publicly funded R&D projects in AMR and the coordination of all R&D actions;
Amendment 357 #
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Welcomes the conclusions of the “WHO, WIPO, WTO Joint Technical Symposium on Antimicrobial Resistance: how to foster innovation, access and appropriate use of antibiotics"4a , where new R&D models were discussed to incentivize R&D while delinking the profitability of an antibiotic from volumes sold; _________________ 4a http://www.wipo.int/publications/en/detail s.jsp?id=4197
Amendment 358 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and the Member States to support the implementation ofexplore new economic models, pilot projects and incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccine, vaccines and medical devices, since the market has failed to sufficiently support the development of new products; recalls that new business models need to be sustainable, needs-driven, evidence-based and guided by the principles of affordability, effectiveness, efficiency and equity, to the benefit of patients;
Amendment 377 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes the hesitant approach of the industry to develop ‘last-line’ antibiotics against bacteria that are resistant to all other antibiotics owing to expected low profitability; recalls for incentives for this research and definition of the regulatory pathwathat, unlike treatments for chronic diseases, antibiotics are temporary medicines which have the potential to cure the patient, meaning that the development of new antibiotics cannot be linked to the usual economic model of the industry;
Amendment 382 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Remembers that both, the European Parliament and the Council have asked for a review of current incentives (i.e orphan medicines regulation), due to their misused and high final prices; calls therefore on the European Commission to analyse current R&D incentive model, including the Transferable Market Exclusivity Model, in order to design new ones and define the regulatory pathway;
Amendment 387 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission and Member States to develop new incentive models that delink payment from prescribing volume; highlights that guaranteeing affordability and access to quality antibiotics must be the final aim of R&D and incentives;
Amendment 392 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Acknowledges the key role of pharmacists in raising awareness around the appropriate use of antimicrobials, as well as in the prevention of AMR; encourages Member States to expand their responsibilities by allowing exact quantity dispensing and enabling the administration of certain vaccines and rapid diagnostic tests within pharmacies;
Amendment 393 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Underlines the importance of working on a definition of R&D costs, where disbursements disconnected from the production chain and direct and indirect subsidies are subtracted;
Amendment 396 #
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Welcomes the WHO ranking list of 20 Worst Antibiotic-Resistant Pathogens5a; calls for urgent R&D projects on this priority list of antibiotic- resistant bacteria in order to create drugs to fight them; highlights however that research on new drugs is not the only action needed and that misused and over- use must be tackled in both humans and animals; _________________ 5a http://www.who.int/mediacentre/news/rele ases/2017/bacteria-antibiotics-needed/en/
Amendment 398 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Recalls that owing to the complexity of the problem, its cross-border dimension, the severe consequences for human and animal health and the high economic burden, AMR requires urgent and coordinated global and intersectoral action; therefore, asks for a clear commitment, on the part of the EU and the Member States, to launch a crosscutting global strategy to combat AMR, covering policy areas such as international trade, development and agriculture;
Amendment 407 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Takes note of the report “Tackling drug-resistant infections globally: final report and recommendations"6a that estimates that taking global action on AMR will cost 40 billion USD over a 10- year period, which is tiny in comparison to the cost of inaction and it is also a very small fraction of what the G20 countries spend on healthcare today: around 0.05 per cent; calls on the European Commission to analyse the possibility to impose a tax on the industry for public health in the framework of its social responsibility; _________________ 6ahttps://amr- review.org/sites/default/files/160518_Fina l%20paper_with%20cover.pdf
Amendment 411 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Welcomes the new WHO guidelines on the use of medically important antimicrobials in food- producing animals7a; highlights that in some countries, approximately 50-70% of total consumption of medically important antibiotics is in the animal sector, largely for growth promotion in healthy animals; asks, in the framework of the One Health approach, to include this topic in the trade policy of the EU and in negotiations with international organisations as the WTO and associated or third countries, shaping a global policy in order to ban the use of antibiotics for fattening healthy animals; _________________ 7a http://www.who.int/foodsafety/areas_work /antimicrobial- resistance/cia_guidelines/en/
Amendment 414 #
Motion for a resolution
Paragraph 26
Paragraph 26
26. Notes that AMR is of serious concern in many poverty-related and neglected diseases (PRNDs), including HIV/AIDS, malaria and tuberculosis (TB); highlights that about 29 % of deaths caused by AMR are due to drug-resistant TB, and calls on the Commission and the Member States to increase their support to research for health tools to address PRNDs affected by AMR, and to create partnerships such as PRIMA or EDCTP for international R&;D projects on health, comprising different geographical regions and the most sensitive health topics such as AMR, vaccines, cancer and access to medicines;
Amendment 419 #
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26 a. Underlines the importance of European initiatives as the ECDC programmes for infectious diseases such as AIDS, TB and malaria; points out that these initiatives are examples of good practices of the responsiveness and good functioning of the EU in view of the need for new antibiotics, and that the ECDC should have a key role in the prioritisation of R&D needs, in the coordination of actions and involvement of all actors, in enhancing cross-sectorial work and in capacity building through R&D networks;
Amendment 421 #
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26 b. Stresses that there is a problem of emergence of multiresistant bacteria, resistant to several antibiotics at the same time that can eventually become superbacteria resistant to all available antibiotics, including last line antibiotics; highlights the need for a database on these multiresistant bacteria as AIDS, TB, malaria, gonorrhoea, Escherichia coli, and other drug-resistant bacteria;
Amendment 423 #
Motion for a resolution
Paragraph 26 c (new)
Paragraph 26 c (new)
26 c. Stresses the enormous challenges of affordability and access to antimicrobials and their impact on public health; highlights that TRIPS flexibilities should be reaffirmed; welcomes the Davos Declaration on Combating Antimicrobial Resistance launched at the World Economic Forum in Davos on January 2016, where pharmaceutical, biotechnology and diagnostics industries “recognise the success of programmes to improve global access to drugs in HIV, TB, and malaria and call for a similar collaborative effort to address issues of access to antibiotics"8a; _________________ 8ahttps://amr- review.org/sites/default/files/Industry_Dec laration_on_Combating_Antimicrobial_R esistance_UPDATED%20SIGNATORIES _MAY_2016.pdf
Amendment 431 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Commission to advocate EU standards and measures for tackling AMR in trade agreements, for the appropriate use of antibiotics;
Amendment 441 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28 a. Notes the importance of universal access to existing antibiotics, in order to ensure targeted treatment with specific antibiotics, which should be available in order to avoid the misuse of unsuitable antibiotics and the overuse of broad- spectrum antibiotics;
Amendment 443 #
Motion for a resolution
Paragraph 28 b (new)
Paragraph 28 b (new)
28 b. Calls on the Commission to take the global lead in advocating for evidence-based best practice models for early diagnosis to tackle AMR;